CTRI/2026/04/109113尚未招募3 期
A bioequivalence, multi center, double blind, randomized, placebo controlled, parallel group study, comparing Diclofenac diethylamine gel, 2.32 percentage (JAMP Pharma Corporation, Canada) to Voltaren Emulgel Extra Strength Extra Fort (Diclofenac diethylamine 2.32 percentage weight by weight) (GlaxoSmithKline Consumer Healthcare ULC, Mississauga, ON L5R 4B2(Canadian Reference Product) and both active treatments to a placebo control in the treatment of acute sprain of lateral ankle.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 360
- 试验地点
- 3
研究概览
简要总结
This Study is Randomized, Double blind, Placebo controlled Clinical trial for comparing the Efficacy and Tolerability of Diclofenac diethylamine 2.32% w/w gel of JAMP Pharma vs Voltaren Emulgel® (Diclofenac diethylamine 2.32% w/w) of GlaxoSmithKline Consumer Healthcare ULC.,Mississauga, ON L5R 4B2 in Patients with Acute Sprain of Lateral Ankles. Sample size is 360: 120 Participants for Test, 120 for Reference and 120 for Placebo, where the primary objective is to confirm the safety of generic Diclofenac diethylamine 2.32% w/w gel/JAMP Pharma (Test) with the marketed Voltaren Emulgel Extra Strength/Extra Fort (Reference) in patients with with Acute Sprain of Lateral Ankles on relief of pain as assessed by the patient by means of a 100 mm visual analogue scale (VAS) (scoring range 0 to 100) after seven days of treatment and secondary objective is to confirm the superiority of Test and Reference to Placebo in pain after seven days of treatment, to estimate the relief of pain of Test product compared to Reference during the treatment period and to demonstrate the tolerability of Test and Reference products.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or Female participant, greater than or equal to 18 years and Less than or equal to 65 years of age at the time of enrolment.
- •2.Diagnosed by physical examination with acute sprain of lateral ankle, Grade I and II (as classified by The West Point Ankle Grading System).
- •3.Injury leading to sprain must have occurred within 24 hours prior to enrolment.
- •4.Pain on movement of injured area [measured on a 100 mm Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (unbearable pain)] greater than or equal to 50 mm immediately prior to randomization.
- •Note: Pain on movement on a Visual Analogue Scale (VAS) will be registered by the participant lying down while the investigator holds the injured leg at 45° and performs gentle supination of the injured ankle to reach an angle of approx.
- •5.Able to understand the requirements of the clinical trial and to agree to return for the required follow-up visits.
- •6.Willingness to avoid use of other topical or systemic analgesic or anti-inflammatory medications during the study period, except permitted rescue medication (Paracetamol 650 mg, or other Investigator-approved rescue medication).
- •7.Willing to provide voluntary written informed consent and data protection declaration before any clinical trial related procedure is performed.
- •8.Female subjects of childbearing potential must: Have a negative urine pregnancy test at screening and agree to use acceptable contraception during the study.
排除标准
- •1.Severe (Grade III) ankle sprain, complete ligament rupture, ankle dislocation, or suspected or confirmed fracture (based on clinical assessment or imaging, if performed) not considered amenable to treatment with topical NSAIDs alone.
- •2.Open skin lesion in the injured area.
- •3.Dermatological conditions, such as eczema or skin infections on the injured area.
- •4.Use of medication (other than the study drugs) for the treatment of complaints caused by the affected area.
- •5.Other inflammatory or painful conditions (e.g. headache, toothache).
- •6.Similar injury of the same area within the last 3 months.
- •7.Debilitating acute or chronic illness.
- •8.Use of long-acting NSAIDs, cyclooxygenase (COX)-2 inhibitors or tramadol in the previous 24 h; any other analgesics in the previous 6 h; use of any other topical products applied to the target site (Treatment by rest, ice, compression, or elevation prior to randomization is allowed).
- •9.Use of Systemic corticosteroid or immunosuppressive drugs in the previous 8 weeks.
- •10.Pregnant or lactating or planning to become pregnant during the study period.
- •11.Participants with or without chronic asthma in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other non-steroidal anti-inflammatory agents.
- •12.History of Osteoarthritis, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis) or fibromyalgia.
- •13.History of asthma, hypertension, myocardial infarction, thrombotic events, stroke, congestive heart failure, impaired renal function or liver disease.
- •14.History of gastrointestinal bleeding or peptic ulcer disease.
- •15.Known allergy to aspirin or other Nonsteroidal Anti-Inflammatory Drug (NSAID), Known hypersensitivity or allergy to Diclofenac diethylamine (investigational product) and excipients of the formulation.
- •16.Use of anticoagulants, ACE-inhibitors, cyclosporine, diuretics, lithium, or methotrexate within the past month prior to entry into the study.
- •18.Current participation or not yet completed period of at least 30 days since ending other investigational device or drug trial(s).
- •19.Unwillingness or inability to comply with the clinical trial procedures.
- •20.Unwillingness to consent to storage, saving and transmission of pseudonymous medical data for clinical trial reasons.
- •22.Participants who are legally detained in an official Institute.
研究者
Dr Peeyush Chansouria
Swami Harshankaranand Ji Hospital & Research Centre
研究点 (3)
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